fluticasone propionate and salmeterol
- Product NDC
- 70518-4406
- 11-digit product format
- 705184406
- Labeler code
- 70518
- Product ID
- 70518-4406_48bdf33a-6e9f-8119-e063-6394a90a26bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate and salmeterol
- Dosage form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203433
- Marketing category
- ANDA
- Marketing start
- 2025-07-27
- Substance
- FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- Active strength
- 100; 50 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- fluticasone propionate and salmeterol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUTICASONE PROPIONATE | 100 ug/1 |
| SALMETEROL XINAFOATE | 50 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O2GMZ0LF5W, 6EW8Q962A5 |
| Rxcui | 896184 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4406-0 | fluticasone propionate and salmeterol | 1 in 1 POUCH | POWDER | 1 | | 3 |
| 70518-4406-0 | fluticasone propionate and salmeterol | 1 in 1 CARTON | POWDER | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4406-0 | 70518440600 | 1 POUCH in 1 CARTON (70518-4406-0) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER | 1 pouch | 2025-07-27 | No | No | Historical |